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HPV-related Oropharyngeal and Uncommon Cancers Screening (HOUSTON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02897427
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 21, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and uncommon cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.

Condition or disease Intervention/treatment
Human Papillomavirus Infection Other: Biomarker Analysis Procedure: Biospecimen Collection Procedure: Ultrasonography

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Other
Official Title: HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial of Men (HOUSTON Study)
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 28, 2027
Estimated Study Completion Date : March 28, 2027

Group/Cohort Intervention/treatment
Screening (specimen collection, HPV testing)

STAGE I: Participants undergo collection of blood and oral gargle samples.

STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, undergo collection of oral gargle sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, and ultrasound once every 6 months for 5 years. Participants also undergo collection of blood.

Other: Biomarker Analysis
Complete HPV testing

Procedure: Biospecimen Collection
Undergo collection of blood and oral gargle samples

Procedure: Ultrasonography
Undergo transcervical ultrasonography
Other Names:
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US

Primary Outcome Measures :
  1. Cancer detection rate of the seropositive group [ Time Frame: Up to 5 years ]
    Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.

  2. Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens [ Time Frame: Up to 5 years ]
    Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants willing to have HPV test

Inclusion Criteria:

  • Stage 1 Inclusion Criteria: United States (US) resident
  • Stage 1 Inclusion Criteria: Fluent in English
  • Stage 1 Inclusion Criteria: Sign an approved informed consent document
  • Stage 2 (longitudinal study) Inclusion Criteria:

    • Eligible for and enrolled in Stage 1
    • Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA
    • Sign an approved informed consent document

Exclusion Criteria:

  • Stage 1 Exclusion Criteria: Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis
  • Stage 1 Exclusion Criteria: Received radiation cancer therapy to the head and neck in the past
  • Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months
  • Stage 1 Exclusion Criteria: Ever had a transplant (stem cell, bone marrow, or solid organ)
  • Stage 1 Exclusion Criteria: Patients who received blood transfusions in the last 6 months
  • Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance
  • Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab and oral rinse at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02897427

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Contact: Erich M. Sturgis 713-792-6920

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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kristina Dahlstrom    713-792-6920      
Principal Investigator: Kristina Dahlstrom         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Kristina R Dahlstrom M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02897427    
Other Study ID Numbers: 2016-0109
NCI-2018-02604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0109 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections